Microcrystalline Cellulose USP/EP
Pharmaceutical USP/EP
Pharmaceutical Excipient

Microcrystalline Cellulose USP/EP

High-purity pharmaceutical grade Microcrystalline Cellulose manufactured under stringent cGMP conditions. This essential excipient is crucial for tablet manufacturing, particularly as a binder and disintegrant in direct compression formulations, providing reliable quality and regulatory compliance.

  • USP/EP Grade Pharmaceutical Excipient
  • cGMP Manufacturing Standards
  • Excellent Binding Properties
  • Comprehensive COA Documentation
  • Direct Compression Compatible
  • Regulatory Compliance Ready
Request Quote Technical Support

Technical Specifications

Chemical Formula: (C6H10O5)n
CAS Number: 9004-34-6
EINECS Number: 232-674-9
Physical State: White to off-white powder
Particle Size: Variable grades available (20-200μm)
pH (1% solution): 5.0-7.5
Loss on Drying: ≤5.0%
Residue on Ignition: ≤0.1%
Heavy Metals (as Pb): ≤10 ppm
Bulk Density: 0.3-0.4 g/cm³
Degree of Polymerization: ≥350
Water Content: ≤5.0% (by Karl Fischer)
Storage Conditions: Store in cool, dry place
Shelf Life: 5 years from date of manufacture
Packaging Options: 25kg bags, 500kg drums

Applications

Tablet Manufacturing
Direct Compression
Binder Agent
Disintegrant
Pharmaceutical Excipient
Hospital Pharmacies
Pharmaceutical Manufacturing
Tablet Hardness Enhancement
Formulation Research
Clinical Formulations
Regulatory Submissions
Reference Standards

Industry-Specific Grades

DRAVYOM offers specialized Microcrystalline Cellulose grades tailored for specific pharmaceutical excipient requirements, ensuring optimal performance and regulatory compliance across diverse tablet manufacturing applications.

USP Grade (United States Pharmacopeia)
pH: 5.0-7.5 Loss on Drying: ≤5.0% Heavy Metals: ≤10 ppm Application: FDA-compliant formulations
EP Grade (European Pharmacopoeia)
Degree of Polymerization: ≥350 Water Content: ≤5.0% Residue on Ignition: ≤0.1% Application: EU regulatory submissions
Direct Compression Grade
Optimized particle size distribution Enhanced compressibility Superior flow properties Application: Direct compression tablets
Reference Standard Grade
Certified particle size analysis Certified Analysis: COA included Traceability: NIST traceable Application: Analytical standards

Quality Standards

DRAVYOM's Microcrystalline Cellulose is manufactured under stringent quality control protocols, meeting international pharmaceutical standards including USP, EP, and cGMP specifications. Our pharmaceutical-grade production ensures consistent performance and regulatory compliance.

cGMP Certified Manufacturing
USP/EP Grade Specifications
Controlled Particle Size
Advanced Analytical Testing
Excellent Binding Properties
Batch-to-Batch Consistency
Comprehensive Certificate of Analysis
Controlled Storage Conditions

Advanced Chemical Properties & Performance

Microcrystalline Cellulose exhibits exceptional physicochemical properties essential for pharmaceutical applications. Its ultra-pure composition and precise particle size distribution ensure reliable performance in demanding tablet manufacturing and formulation applications.

Physical Properties
Bulk Density: 0.32 g/cm³
Tapped Density: 0.45 g/cm³
Particle Size (D50): 50 μm
Moisture Content: ≤5.0%
Thermal Properties
Melting Point: Decomposes at 260°C
Glass Transition: Not applicable
Thermal Stability: Stable up to 200°C
Hygroscopicity: Low moisture uptake
Pharmaceutical Performance
Compressibility: Excellent direct compression
Binding Capacity: Superior tablet hardness
Disintegration: Rapid tablet breakdown
Flow Properties: Good powder flow
Purity Specifications
Cellulose Content: ≥97.0%
Ash Content: ≤0.1%
Heavy Metals: ≤10 ppm
Microbial Limits: USP compliant
Stability Properties
Shelf Life: 5 years (unopened)
Light Sensitivity: Stable
Temperature Stability: Stable at room temperature
Container Compatibility: Standard pharmaceutical containers

Performance Characteristics

Detailed performance metrics demonstrate Microcrystalline Cellulose superiority in pharmaceutical applications with exceptional binding capacity, compression properties, and reproducibility across diverse formulation requirements.

Compressibility

Hardness: 8-15 kP with 5% binding

Superior direct compression properties
Binding Capacity

Efficiency: 95%+ tablet integrity

Strong inter-particle bonding
Disintegration

Time: ≤15 minutes in water

Rapid tablet breakdown for release
Thermal Stability

Working range: 15-40°C processing

Stable during tablet compression
Batch Reproducibility

Variation: ±2% between batches

Consistent lot-to-lot performance
Shelf Stability

5 years under proper storage conditions

Extended pharmaceutical grade integrity

Safety Information

Generally recognized as safe (GRAS) for pharmaceutical use. Non-toxic cellulose derivative with excellent biocompatibility. Handle with standard pharmaceutical manufacturing precautions including dust control measures and appropriate protective equipment.

GRAS Status
Low Dust Generation
Biocompatible

Storage & Handling

Store in original sealed containers in a cool, dry, well-ventilated area away from moisture. Keep containers tightly closed and protect from direct sunlight. Use appropriate dust control measures during handling and processing operations.

Cool storage (15-25°C)
Low humidity environment
Original sealed containers
Protect from direct sunlight

Chemical Mechanisms & Reaction Pathways

Microcrystalline Cellulose exhibits unique binding and disintegration properties through hydrogen bonding networks and capillary action mechanisms, enabling precise pharmaceutical applications with superior compactibility and drug release characteristics.

Hydrogen Bonding

Extensive hydrogen bonding between cellulose chains creates strong tablet matrix

Excellent binding properties for direct compression
Capillary Action

Rapid water uptake through capillary channels enables fast disintegration

Enhanced drug release and dissolution profiles
Particle Deformation

Plastic deformation under compression creates strong inter-particle bonds

Superior tablet hardness and mechanical strength
Swelling Mechanism

Controlled swelling promotes tablet disintegration without gelling

Consistent disintegration across various formulations

Regulatory Compliance & Documentation

Comprehensive regulatory compliance ensures global pharmaceutical access with complete documentation packages supporting international standards and excipient regulatory requirements.

USP-NF Specifications

United States Pharmacopeia-National Formulary excipient standards compliance

EP Standards

European Pharmacopoeia specifications for pharmaceutical excipients

GRAS Status

Generally Recognized as Safe for pharmaceutical and food applications

IPEC Guidelines

International Pharmaceutical Excipients Council quality standards

CEP Certificate

Certificate of Suitability to European Pharmacopoeia Monograph

Safety Documentation

Complete safety and toxicological data package

Technical Support & Value-Added Services

DRAVYOM's formulation science team provides comprehensive excipient application support, direct compression guidance, and technical solutions to maximize Microcrystalline Cellulose performance in your pharmaceutical formulations.

Formulation Development
  • Direct compression optimization
  • Tablet hardness and friability improvement
  • Disintegration time optimization
  • Drug loading capacity studies
Analytical Services
  • Particle size distribution analysis
  • Compactibility profiling
  • Flow property testing
  • Moisture content analysis
Technical Support
  • Tableting troubleshooting consultation
  • Manufacturing scale-up guidance
  • Quality control method development
  • Regulatory documentation support
Supply Solutions
  • Multiple grade specifications available
  • Flexible packaging configurations
  • Just-in-time delivery programs
  • Global excipient distribution network

Environmental Impact & Sustainability

Our Microcrystalline Cellulose production emphasizes environmental responsibility through sustainable excipient manufacturing practices, renewable raw material sourcing, and comprehensive environmental impact management.

Renewable Source

Derived from sustainable wood pulp and plant-based cellulose sources

Water Conservation

Advanced water recycling and treatment systems in production

Clean Production

Energy-efficient processing with minimal environmental impact

Biodegradable

Naturally biodegradable excipient with minimal environmental persistence

ISO 14001

Environmental management system certified production

Carbon Footprint

Optimized logistics and regional sourcing strategies

Manufacturing Excellence & Quality Control

DRAVYOM's state-of-the-art excipient manufacturing facility employs advanced processing technology and continuous monitoring systems to ensure consistent Microcrystalline Cellulose quality and performance across all production batches.

Production Process

Advanced controlled microcrystallization in clean pharmaceutical environment

Precise particle size control for optimal tablet performance
Quality Testing

Comprehensive testing including compactibility and flow properties

Laser diffraction and texture analysis verification
Quality Systems

ISO 9001:2015 with pharmaceutical excipient manufacturing certification

IPEC-compliant quality management systems
Packaging Control

Pharmaceutical-grade containers with moisture barrier protection

Maintains functionality and prevents degradation

Market Applications & Performance Data

Comprehensive pharmaceutical development data demonstrating Microcrystalline Cellulose effectiveness across diverse formulation applications with quantified compression, disintegration, and manufacturing performance metrics.

Direct Compression
Compactibility: Excellent binding at low compression forces Disintegration: <15 minutes typical performance Hardness: 4-12 kP tablet strength range
Manufacturing Benefits
Flowability: Good to excellent flow properties Compatibility: Universal API compatibility Efficiency: 30-40% reduction in processing time
Production Performance
Consistency: <5% batch-to-batch variation Yield: >95% tablet production efficiency Cost-Effectiveness: 20% formulation cost reduction

DRAVYOM Competitive Advantages

Superior Quality

Consistently exceeds USP-NF specifications with optimized particle size distribution and functional properties

Reliable Supply

Guaranteed availability with strategic inventory management and multiple-grade production capabilities

Formulation Expertise

Dedicated formulation science team provides direct compression and tablet optimization guidance

Quality Assurance

Comprehensive certificates with complete analytical data and functional property specifications

Global Standards

International compliance with USP-NF, EP, and IPEC specifications for worldwide pharmaceutical acceptance

Partnership Approach

Collaborative relationships with pharmaceutical manufacturers and custom grade development services